N-acetylcysteine (NAC) is a powerful antioxidant that was approved as a drug in September 1963.1 It has since been used as a dietary supplement not found in natural sources.2 NAC contains the amino acid cysteine, which is a precursor to glutathione, which is also called the “major antioxidant”.3
Glutathione consists of three amino acids – glutamic acid, glycine and cysteine.4 However, NAC is only available as add-ons. Precursors of NAC can be found in foods high in cysteine, which include pork, beef, chicken, eggs, dates, and sunflower seeds.5
NAC is used in prescription form as an antidote to acetaminophen-induced hepatotoxicity.6 It is also a potent mucolytic agent for use in upper respiratory tract conditions. Sloan-Kettering Memorial7 it also cites use in the treatment of depression, precancer, HIV and AIDS, and to alleviate the side effects of cancer treatment.
In 2020, the NAC announced the news when the FDA decided that the sale of this compound without a prescription, which was available for 57 years at the time, should require a prescription in the future. The FDA has issued warning letters8 seven companies the agency said were illegally selling hangover products. By May 2021, Amazon, which also owns Whole Foods, has decided to remove all supplements containing NAC.9
The FDA is seeking more information on the NAC
According to Natural Products Insider, the letters warn that the NAC cannot “legally be placed on the market in dietary supplements because it was first studied as a medicine in 1963.”10 The Responsible Nutrition Council (CRN) sent a letter in December 2020 to the FDA’s Office of Nutritional Supplements Programs describing the situation as “legally invalid”.11
The CRN and the Natural Products Association (NPA) have submitted separate petitions to citizens to the FDA. A CRN letter in December 2020 challenged the FDA’s decision that the NAC should be excluded from additional use.12 Then, on June 1, 2021, they filed a petition for the attitude of the citizens, asking the FDA to change its position and stating why this sudden change in policy is “legally invalid on several grounds.”13
The NPA has submitted a separate petition of citizens to the FDA14 requiring the agency not to exclude NAC as a dietary supplement or, alternatively, for the Ministry of Health and Social Services (HHS) to issue a regulation establishing that NAC is legal in supplements. Although the HHS has authority, it has not been used in the 27 years since a law was passed in 1994 giving HHS such authority.
On November 24, 2021, the FDA announced that it was seeking more information on how the NAC is being marketed as a dietary supplement.15 Natural Products Insider reports that this was encouraging for some in the industry as it signaled that the FDA was open to the idea of issuing a regulation that the NAC is a legal ingredient in dietary supplements.16 The FDA called this:17
“… probationary responses to both citizens’ petitions, seeking additional information from the applicant … and noting that the Agency needs additional time to carefully and thoroughly review the complex issues raised in these petitions.”
FDA18 it also requested information and data on the date when the NAC was first placed on the market as a dietary supplement, reports on side effects and details on how the products are marketed and sold. Data is requested until January 25, 2022. Steve Mister, President and CEO of CRN said in a statement:19
“The provisions of the 1994 Health and Education Supplements Act (DSHEA) must not be interpreted retroactively to remove ingredients that were lawfully placed on the market in 1994 and have since enjoyed a long history of safe use. Delay in clarifying the status of the NAC by requesting more information and refusing to admit its error ignores the law and harms consumers who use the NAC.
This is not a complicated decision to be made by the FDA. DSHEA makes it clear that ingredients used as ingredients in dietary supplements before being introduced to the diet. Thus, drug manufacturers in the years before the enactment of this provision of the law could not expect exclusivity.
Given the long history of safe use of NAC, the FDA cannot now attempt to establish safety concerns to assign this ingredient exclusively to drug manufacturers. ”
The FDA used a legally questionable drug exclusion provision for the first time
American Code Title 21,20 specifically defines what is a dietary supplement and what is not. According to experts, the actions of the FDA in banning the sale of NAC and finding that the “drug” is illegal under the law. Lawyer Stan Soper21 states that under Title 21 § 321 paragraph (ff) (3) (b) 10 the actions of the FDA do not comply with the Exclusion Provision.
According to Soper,22 the exclusion provision has been invoked only a few times, especially when used to prevent the sale of red yeast rice, vitamin B6 and cannabidiol (CBD) as supplements. In each of these cases, there was a potential pharmaceutical financial loss that prompted the claim that the supplement was illegal.
In the case of red yeast rice, it contains a natural substance that acts in a similar way to Lovastatin, a statin medicine.23 In 2005, drug maker Biostratum applied for research from the FDA’s new drug (IND) for the use of vitamin B6 in the treatment of diabetic kidney disease.
Their argument was that “there is no evidence that it was marketed as a dietary supplement or food before the IND and Phase II research”.24 In 2009, the FDA declared vitamin B6 as a dietary supplement despite documentation that it was sold as such before the IND application.
The FDA also referred to the Anti-CBD Exclusion Ordinance, warning that it is not a legal dietary supplement as there was no significant evidence that it was marketed as such before investigations were approved into drugs for Sativex and Epidiolex, which are drugs containing CBD.
After the 2018 Hemp Farm Law was signed, then-FDA Secretary Dr. Scott Gottlieb made a statement that it was illegal to introduce CBD into the food supply or put it on the market as a supplement.25 Great postulates26 that the use of the CBD Exclusion Ordinance may have opened the door for the FDA to use it against the NAC.
Why target NAC?
In the petition of the citizens27 sent to the FDA on June 1, 2021, the CRN argued that the FDA had failed to adequately explain this sudden change in NAC policy, making it “arbitrary and capricious”. According to CRN, before seven warning letters in July 2020, “the FDA’s long-standing policy was to allow the marketing of dietary supplements containing NAC.”
Although the agency has reviewed more than 100 requirements for the structure / function of notifications for supplements containing NAC over the years, they have never raised a drug exclusion clause. In one response to a petition for a qualified health claim, the FDA even stated that the NAC is considered a dietary supplement.
Although the CBD Exclusion Ordinance may have opened the door, it still raises the question of why the FDA has decided to target the NAC now. Historically, this provision has been inappropriately used to protect the finances of pharmaceutical companies. It is also probably the root of the motivation to ban the NAC as an adjunct.
As pulmonologist Dr. Roger Seheult summarizes in the MedCram video below, NAC is a key chemical compound necessary to reduce oxidative stress associated with severe COVID-19 infections and can therefore significantly affect antiviral drug sales. And, as I and other health experts have pointed out in the past, without a serious illness, is there really a need for a vaccine?
Decreased glutathione worsens COVID-19 outcomes
Researchers have been studying NAC since it was discovered. In 2010,28 researchers have found that it can inhibit the expression of proinflammatory cytokines in cells infected with the highly pathogenic H5N1 influenza virus. These same proinflammatory cytokines play a key role in severe COVID-19 disease.
Researchers have confirmed that in severe cases, cytokine levels are elevated and when they reach excessive levels, this triggers a cytokine storm.29 This causes significant tissue damage that NAC can inhibit. In one paper from 2020.30 the authors describe a case of COVID-19 in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency.
This is a genetic disorder that can lead to hemolytic anemia31 and depletes glutathione,32 increases the risk of coronavirus infections in humans such as the common cold. NAC was assigned to a G6PD deficient patient and nine other patients with COVID on respirators. The NAC “caused clinical improvement and significantly reduced CRP in all patients.”33
Other published papers since then have shown that there is a potential use of NAC in the treatment of COVID-19.34,35,36 One study from 202137 compared consecutive patients hospitalized with moderate or severe pneumonia from COVID-19.
One group received only standard care and the other received 600 mg of NAC twice daily for 14 days. There were 42 in the NAC group and 40 in the control group. NAC treatment resulted in lower rates of severe respiratory failure and significantly lower mortality rates.
Early treatment at home is crucial
The NAC is just one in a series of treatment modalities that have proven successful, but have been denigrated by government agencies. Since the beginning of this pandemic, global and national health authorities seem to have done everything in their power to discourage and prevent people from accessing treatment, such as ivermectin38,39,40 and hydroxychloroquine,41,42,43,44 competing with the COVID sting.
The actions around the NAC seem to be another shameful attempt to prevent patients from helping themselves. By restricting access to dietary supplements that have shown the ability to reduce the severity of infection, agencies are essentially increasing the risk of infections progressing to more serious cases.
If you get symptoms of COVID-19, early treatment is crucial. Not only can it significantly shorten the time you are sick, but early treatment will also reduce the risk of long-term carrier syndrome,45 which may include symptoms that last much longer than the original infection.46 These can include cough, body aches, difficulty sleeping, headaches and brain fog.
There is also scientific evidence that NAC can improve a variety of lung problems, including pneumonia and acute respiratory distress syndrome (ARDS), common features of COVID-19. For example:
- Research47 published in 2018 found that NAC reduces oxidative and inflammatory damage in patients with community-acquired pneumonia.
- Another study from 201848 found that NAC improves postoperative lung function in patients undergoing liver transplantation.
- Metaanalysis from 201749 found a significant reduction in intensive care among patients with ARDS treated with NAC.
- NAC is also a well-known mucolytic used to clear mucus from the airways of patients with cystic fibrosis.50 Some studies also suggest that NAC may help reduce COPD symptoms and prevent worsening of the condition.51